Allmedic “TruPDT” has raised many questions
We suggest that doctors seek answers to the following questions before making a decision to use the Allmedic “turnkey” system.
ALA
Allmedic claim their ALA is stable in the medium they distribute it. Other companies have indicated that they are not able to stabilise ALA in this way and have suggested it cannot be done. There are reports of apparent considerable variation from batch to batch of Allmedic ALA. For example, several patients receiving a single batch may get an excessive response while others being treated with a different batch appear to have a minimal or absent response to application and illumination.
Furthermore, therapeutic devices such as a photodynamic therapy (PDT) actiivation light source must be approved in advance by the Therapeutic Goods Administrtion (TGA) before it is approved for usage to manage patients.This is the case regardles of the indication of the PDT.
As such, ask Allmedic:
Provide independent data and evidence that Allmedic ALA is stable and has a lengthy shelf life when refrigerated as recommended and ensure this data notes the source of the independent testing facility so as the data provided can be verified?
Provide proof of TGA approval of this ALA product?
Provide evidence of uniformity of production?
Explain active monitoring and recall systems?
Provide evidence that the Allmedic light activation source is TGA approved.
A word of caution is needed as Allmedic has been known to provide a simple one page sheet that they claim is proof of their ALA stability. This sheet provides none of the usual requirements of an independent stability / safety report. The amateur graph provided does not even include confidence limits or other indication of batch to batch variation. Instead, marketing words are used in this one page sheet such as "remarkable" and "extraordinary". A truly independent scientific report would remain objective and would not include such marketing terminology. Details of methodology, numbers tested and variations in conditions, etc, are conspicuous by their absence in this simple sheet.You can download their concerning stability claim sheet here.
PDTEze
There are perhaps even greater concerns regarding Allmedic’s PDT Eze. This product has been described by Allmedic as a “patent pending innovation” and a “landmark discovery”. Allmedic claim that “for patients undergoing PDT as it has proven to reduce pain scores by approximately 70% . .” Several academics including Associate Professor Dixon have conducted the usual medical research literature reviews on this product. Not only have no favourable studies been found, but no studies at all have been found. Indeed no mention of PDT Eze can be found in any reputable medical or scientific journal as of February 2010. Indeed we are not aware of any ethics approved and registered trial currently underway regarding PDT Eze.
In May 2009 Allmedic presented a so called “study” of PDT Eze at a cosmetic conference in Sydney. They describe a tiny study undertaken by doctors who are also Allmedic shareholders and Board members. This study was apparently a split face type study. The study was not independent, not validated and has not been published. Clearly such a study has no scientific credibility. We have dismissed this report. We hope it is not this study that Allmedic rely on for their claims of 70% reduction in pain scores. Yet we are not aware of any studies.
Allmedic has also claimed that “post PDT inflammation is also markedly reduced. Some patients are reporting no pain at all on days 0-3.” This claim is concerning. Many doctors anecdotally state that the patients who have the more vigorous reaction and discomfort following PDT are the patients that seem to get the greater medium and long term reduction of actinic keratoses. Doctors have often commented that “No pain – no gain” seems to be a truism of PDT.
Truth is, we don’t really know. Interestingly, the same “No pain – no gain” phenomenon has been noted when imiquimod is used to manage superficial BCCs. Clinicians are often concerned and warn patients that another treatment is likely to be required when imiquimod does not invoke inflammation and discomfort.
As such, there remains the very real possibility that PDT Eze may markedly reduce pain and inflammation and also markedly reduce any effect the PDT might be having on their sun damaged skin. Large prospective and independent longitudinal studies over several years comparing PDT with and without PDTEze would be required to answer this important question. To our knowledge, no such studies exist.
Having said that, there are doctors who have early favourable experience with usage of this product. It appears to be a good idea that has yet to be formally validated and tested. As such we suggest you ask Allmedic:
· What is the mystery compound in PDT Eze?
· Is it proven to be safe to put on the face of Australians?
· What human safety studies have been done?
· What human longitudinal prospective independent studies have been undertaken?
· Provide copies of independent studies of safety and efficacy of PDT Eze?
· Provide evidence through independent research and data that the sustained reduction of actinic keratoses is not altered when PDT Eze is used during treatment?
· Can you provide full manuscripts of all clinical studies?
· Provide proof of TGA approval of PDT Eze?
If these answers cannot be provided, not only does Skincanceronly suggest you do not use the product but we suggest that the product should not be on the market and available to humans at this time.
Indeed if these questions cannot be answered regarding PDT Eze, it is the view of Skincanceronly that usage of PDT Eze should be completely restricted to ethics approved prospective studies designed to confirm human safety and efficacy of the product.
Skincanceronly has asked all these questions of Allmedic and has allowed time for them to respond. Even 12 months later Allmedic has not answered these questions in any way other than to confirm that none of their PDT products are TGA approved as of March 5, 2010. As such, we cannot endorse usage of these products. You might obtain answers to these questions that were not provided to Skincanceronly. If you are provided with such answers, we would love to hear from you. If you are agreeable, we will provide those answers on this page in the interests of public safety.
Associate Professor Anthony Dixon